On 9 June 2023, the UK Government published further guidance relating to the practical implementation of the Windsor Framework (agreed between the UK and the EU on 27 February 2023, please see our client alert here). This overarching guidance contains further detail from the Medicines and Healthcare products Regulatory Agency (“MHRA”) on the implementation
Following the COVID-19 pandemic and the relatively slow approval of vaccines in the EU versus other key jurisdictions, as part of the EU’s General Pharmaceutical Legislation amendment proposal, published on 26 April 2023, the European Commission has proposed to introduce temporary emergency marketing authorizations (“TEMAs”) for use when there is a “public health emergency.”
As highlighted in our recent series of blog posts (please see our Inside EU Life Sciences blog series here), the European Commission has at long last published its proposal to overhaul EU legislation for human medicinal products.
On 26 April 2023, the Commission published its proposal for a new human medicines directive (the “Proposed Directive”) to replace the current European Medicines Directive (Directive 2001/83/EC); as well as a regulation for centrally authorised medicines (the “Proposed Regulation”) to replace the current Regulation 726/2004.
Medicines advertising and promotion rules are of key interest to pharmaceutical companies operating in the EU. This blog looks into how the new legislative proposal might affect the advertising landscape, focusing on the Proposed Directive (whose advertising provisions also apply to products covered under the Proposed Regulation).
For those of you who are perhaps breathless from the suite of new proposals, advertising and promotion may appear to be one small area to exhale in relief. However, some of the proposed changes may have significant practical implications, particularly for comparative advertising.
The headline news is that – for advertising – the Proposed Directive largely maintains the status quo. It remains aligned almost entirely with the current framework, supplementing rather than revolutionizing current law.
The evolutionary approach is unsurprising. EU-level law is really only the “tip” of the proverbial “iceberg” when it comes to pharmaceutical advertising in Europe. Many operational rules are nationally diverse, and found in national laws, codes and rulings. Moreover, in practice, pharmaceuticals advertising is often largely governed and enforced through the self-regulatory system and self-regulatory codes, such as the Code of Practice of the European Federation of Pharmaceutical Industries and Associations (the “EFPIA Code”) and its various national incarnations. The Explanatory Memorandum to the Proposed Directive suggests legislators have tried to avoid overhauling the intricate framework regulating advertising. Nevertheless, the Proposed Directive does make some changes to advertising rules. Most are generally uncontroversial and/or “tidy ups”; but others may be more significant, particularly supplementing the definition of “advertising” and new provisions on comparative advertising. Continue Reading EU Pharma Legislation Review Series: Advertising Updates Reflect Evolution Rather than Revolution
Pharmaceutical companies take note: the EU plans to refuse marketing authorizations for environmentally-unfriendly medicines.
The EU has published a package of revisions to the bloc’s common pharmaceutical regime. Many revisions aim to reduce the environmental impact of human medicinal products. The key environmental measures include:
In this post, we lay out what pharmaceutical companies need to know about the key environmental measures.Continue Reading EU Pharma Legislation Review Series: Addressing Environmental Risks
In this episode of Covington’s Life Sciences Audiocast, Sarah Cowlishaw and Ellie Handy discuss the recent changes to the MDR and IVDR. Our speakers discuss the European Commission’s recently adopted Regulation (EU) 2023/607, which extends the transitional periods in the EU Medical Devices Regulation (EU) 2017/745 (the “MDR”) for certain eligible devices CE marked
Complex international pharmaceutical supply chains often separate the physical flow of product from financial flows or flows of legal title. Tune in to this episode of Covington’s Life Sciences Audiocast, where Grant Castle, Robin Blaney and Marie Doyle-Rossi, discuss how the EU and UK pharmaceutical rules seek to regulate these tax and
Tune into the third episode of Covington’s Life Sciences Audiocast, where Grant Castle, Stefanie Doebler, and Raj Gathani discuss social media challenges for pharma companies in Europe and the U.S.
To avoid a real and imminent risk of shortages of devices on the EU market, the European Commission recently adopted Regulation (EU) 2023/607, extending the transitional provisions in Regulation (EU) 2017/745 (the “MDR”) and removing the sell-off period in the MDR and Regulation (EU) 2017/746 (the “IVDR”). The Commission has published a Q&A on the practical aspects of the latest changes (the “Q&A”). We set out the top 10 questions to think about when assessing how the changes to the MDR and IVDR may impact you and your medical devices.
Continue Reading How do the recent changes to the MDR and IVDR impact you and your medical devices? — Top 10 Questions
Last week, Jeremy Hunt, Chancellor of the Exchequer, published his Spring Budget for the UK. It identified life sciences and digital technologies as “high growth sectors,” which the UK Government wishes to prioritize. Among other things, the Budget outlined the Government’s plans to simplify medicines and technology approvals, plus changes to the regulation
On 14 February 2023, the German Federal Ministry of Health (BMG) has presented the new draft “Act to Combat Supply Shortages of Off-Patent Medicines and to Improve the Supply of Paediatric Medicines” (Arzneimittel-Lieferengpassbekämpfungs- und Versorgungsverbesserungsgesetz or “ALBVVG”). Some commentators also refer to the new law as the “Generics Act” but